Articles related to DEVICE/DRUG APPROVALS

Basimglurant is a highly selective, potent, and cell-penetrant negative allosteric modulator of metabotropic glutamate receptor 5 (mGluR5). Based on the LibraTN trial — a 24-week, prospective, double-blind, randomized-withdrawal, placebo-controlled study of basimglurant for trigeminal neuralgia, FDA has granted the molecule Fast Track designation.

The FDA Oncologic Drugs Advisory Committee (ODAC) unanimously decided on October 28 that there is insufficient evidence to support the claim that the pediatric oncology drug 131-I-omburtamab improves overall survival. A radiolabeled antibody, 131-I-omburtamab was created to treat central nervous system/leptomeningeal (CNS/LM) metastases in pediatric patients with neuroblastoma.

The FOENIX*-CCA2 trial, a global phase 2, open-label trial examining 103 patients with unresectable, locally progressed, or metastatic iCCA harboring FGFR2 gene rearrangements including fusions, was the basis for the approval of futibatinib (Lytgobi, Taiho Oncology). Patients in this trial received 20 mg of futibatinib orally once daily until disease progression or intolerable toxicity; the primary end goal was achieved with a 42% objective response rate as determined by an impartial central evaluation. With 72% of responses lasting at least six months, the median response time was 9.7 months.

The MajesTEC-1 trial, a phase 1/2 open-label research that revealed effectiveness data from 110 patients with relapsed or refractory multiple myeloma, provided evidence from strong response rates that served as the foundation for the approval. The accelerated approval of a bispecific antibody for the incurable blood malignancy is a first of its kind in the US. Proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody must have been used in prior therapy.

The oral suspension formulation was developed for patients who have difficulty swallowing the tablet form of the PDE5 inhibitor.

In 2023, patents for the two blockbusters Humira and Stelara will expire. The patents for Aranesp, Rituxan, Simponi, and others will expire in 2024, and in 2025, six more blockbuster drugs will experience patent expiration, opening the field to a rush of biosimilars. That could create an environment of significantly reduced drug prices.